none, vaccine was administered past the 10 week EAU expiration date.

Document Type: History and Physical Document Subject: History & Physical Note Performed By: MD on January 20, 2025 13:46 Verified By: MD on January 20, 2025 13:46 Encounter Info: Hospital, Inpatient, 01/20/25 – * Final Report * Chief Complaint Diarrhea History of Present Illness/Subjective Patient is an 83 year old woman who presents to the ER w/ diarrhea and abd pain for the last 3 days. Patient endorses watery diarrhea, no blood. She has also had abd pain and increased urinary frequency. She denies any fever. Upon arrival to the ER she was tachycardic and afebrile. BP was 91/60. Labs were notable for a WBC count of 12. Hgb was 11. Na was 129 and Cr was 2.6. CT abd/pelvis showed e/o colitis. Lactate was 2.3 but repeat was normal. Patient was given fluids and admitted to the medicine service for further management. Review of Systems With the exception of that noted in the HPI all systems were reviewed and were negative. Physical Exam/Objective Vitals & Measurements most recent past 24 hours Constitutional: No acute distress, well-nourished Eyes: no scleral icterus ENMT: Moist oral mucosa Respiratory: CTAB Cardiovascular: Regular rate and rhythm, no MGR Gastrointestinal: non-distended, tender to palpation Musculoskeletal: intact ROM Integumentary: no rashes Neurologic: no focal deficits Psychiatric: Cooperative, appropriate mood and affect Assessment/Plan 1. Colitis K52.9 -Unclear cause -GIP panel -GI consult -Zosyn 2. AKI (acute kidney injury) N17.9 -Pre-renal in nature -LR at 100cc/hr -PVR urine -Renally dose meds 3. Dehydration E86.0 -Fluids as above 4. Hyponatremia E87.1 -The patient presents with a electrolyte imbalance including hypo-osmolality and hyponatremia. Continue to trend serial analysis as appropriate with replenishment of electrolyte imbalance as required for stabilization. -Hypovolemic -Fluids as above 5. Anemia D64.9 -The patient presents with anemia chronic and normocytic due to other chronic disease at present is stable. Continue to trend serial analysis as appropriate with nutritional or blood product supplementation as required. 6. Leukocytosis D72.829 -Non-specific finding -Likely due to colitis 7. GERD (gastroesophageal reflux disease) K21.9 -Continue PPI 8. Hyperlipidemia E78.5 -Continue statin Code Status Full Code Chronic Problem List Acute respiratory failure Anemia Cervical radiculopathy CKD (chronic kidney disease), stage II COPD (chronic obstructive pulmonary disease) COPD bronchitis COVID DDD (degenerative disc disease), cervical DDD (degenerative disc disease), lumbar GERD (gastroesophageal reflux disease) Goiter Hematuria History of peptic ulcer Hyperlipidemia Hypoalbuminemia Long term use of drug Lumbar radiculopathy Lung nodule Osteoarthritis Osteopenia PE (pulmonary thromboembolism) Pneumonia Postmenopausal Reactive thrombocytosis Smoking Thrombocytosis UTI (urinary tract infection) Procedure/Surgical History ?Back surgery (07/17/2024) ?colonoscopy (05/15/2014) ?small bowel capsule (04/29/2014) ?egd (04/24/2014) ?back surgery (05/2010) ?abdominal laparotomy multiple times ?c-section ?cataract removal with lens implants ?goiter removed from neck ?hysterectomy ?lumbar surgery ?rotator cuff repair right shoulder Surgical History Internal 06/17/2024 Spine Fusion Posterior Lumbar (Postr) MD 04/02/2018 Spine Fusion Posterior Lumbar MD 03/07/2016 Lumbar Laminectomy (Left) MD Medications Home Medications (10) Active albuterol 2.5 mg/3 mL (0.083%) inhalation solution 2.5 mg = 3 mL, PRN, Neb Inhal, Q6H, COPD atorvastatin 20 mg oral tablet 20 mg = 1 Tablet, Orally, QHS DME (Vendor) Oxygen See DME Order Details or printed requisition for more information., This is a print requisition order, cannot be ePrescribed. DULOXetine 30 mg oral delayed release capsule 30 mg = 1 Capsule, Orally, Daily, TAKE 1 CAPSULE BY MOUTH DAILY gabapentin 100 mg oral capsule 100 mg = 1 Capsule, Orally, 4 Times Daily hydroxyurea 500 mg oral capsule 1 Capsule, Orally, Daily Magic Potion oral solution 5 mL, Orally, 4 Times Daily, Swish and Spit montelukast 10 mg oral tablet 10 mg = 1 Tablet, Orally, Daily OXYcodone-acetaminophen 7.5 mg-325 mg oral tablet 1 Tablet, PRN, Orally, Q4H pantoprazole 40 mg oral delayed release tablet 40 mg = 1 Tablet, Orally, Daily Active Scheduled Inpatient Medications Sodium Chloride 0.9% 500 mL IV Continuous 42 mL/hr Days 1, 8 One-Time Medications Given 01/19/25 00:00:00 TO 01/20/25 13:41:14 None Reported PRN Medications (0600 – 0559) from 01/19 – 01/20 None Reported Allergies Eggs (Blisters) No Known Medication Allergies Social History Alcohol Denies Electronic Cigarette/Vaping E-Cigarette Use Never. Home/Environment Lives with Spouse, 35YR OLD GRANDSON. Nutrition/Health Diet: Regular. Substance Abuse Denies Tobacco Tobacco Use: Former smoker, quit more than 30 days ago. Started age 16.0 Years. Stopped age 83 Years. Family History Breast cancer: Mother. Cancer of colon: Daughter. Diabetes mellitus type 2: Mother. Heart attack..: Mother. Prostate cancer..: Father. Deceased Family Member(s) Relationship: Mother, Age: Unknown, Cause: DM, CA of breast, heart Relationship: Father, Age: Unknown, Cause: Bladder CA, Prostate CA then to Bone Lab Results All Labs Last 24 hours (No Micro or Pathology) Hematology: WBC: 12 k/cumm High (01/20/25 08:08:00) RBC: 3.24 million/cumm Low (01/20/25 08:08:00) Hgb: 11.8 GM/dL Low (01/20/25 08:08:00) Hct: 35.6 % (01/20/25 08:08:00) MCV: 110 fL High (01/20/25 08:08:00) MCH: 36.5 pg High (01/20/25 08:08:00) MCHC: 33.2 GM/dL (01/20/25 08:08:00) RDW: 24.1 % High (01/20/25 08:08:00) Platelet: 212 k/cumm (01/20/25 08:08:00) MPV: 8.5 fL (01/20/25 08:08:00) Neutrophils %: 94 % (01/20/25 08:08:00) Lymphocytes %: 3 % (01/20/25 08:08:00) Monocytes %: 3 % (01/20/25 08:08:00) Eosinophils %: 0 % (01/20/25 08:08:00) Basophils %: 0 % (01/20/25 08:08:00) Absolute Neutrophil: 11.3 k/cumm High (01/20/25 08:08:00) Absolute Lymphocyte: 0.4 k/cumm Low (01/20/25 08:08:00) Absolute Monocyte: 0.4 k/cumm (01/20/25 08:08:00) Absolute Eosinophil: 0 k/cumm (01/20/25 08:08:00) Absolute Basophil: 0 k/cumm (01/20/25 08:08:00) Chemistry: Sodium SerPl QN: 129 mmol/L Low (01/20/25 08:08:00) Potassium SerPl QN: 5.5 mmol/L (01/20/25 08:08:00) Chloride SerPl QN: 95 mmol/L Low (01/20/25 08:08:00) Carbon Dioxide SerPl QN: 25 mmol/L (01/20/25 08:08:00) Anion Gap: 9 mmol/L (01/20/25 08:08:00) BUN SerPl QN: 60 mg/dL High (01/20/25 08:08:00) Creatinine SerPl QN: 2.63 mg/dL High (01/20/25 08:08:00) Estimated GFR (CKD-EPI, no race): 18 mL/min/1.73m2 Low (01/20/25 08:08:00) Estimated CRCL (CG): 9 mL/min Low (01/20/25 08:08:00) Glucose SerPl QN: 175 mg/dL High (01/20/25 08:08:00) Calcium Total SerPl QN: 7.4 mg/dL Low (01/20/25 08:08:00) Alkaline Phos SerPl QN: 92 Units/L (01/20/25 08:08:00) ALT SerPl QN: 15 Units/L (01/20/25 08:08:00) AST SerPl QN: 47 Units/L High (01/20/25 08:08:00) Bilirubin Direct SerPl QN: <0.1 (01/20/25 08:08:00) Bilirubin Total SerPl QN: 0.6 mg/dL (01/20/25 08:08:00) Total Protein SerPl QN: 5.1 GM/dL Low (01/20/25 08:08:00) Albumin SerPl QN: 2.5 GM/dL Low (01/20/25 08:08:00) Magnesium SerPl QN: 1.8 mg/dL (01/20/25 08:08:00) Lipase SerPl QN: 4 Units/L Low (01/20/25 08:08:00) Lactate Venous Pl QN: 1.4 mmol/L (01/20/25 11:09:00) All Other Labs: COVID 19 Specimen Source: Nasal (01/20/25 08:29:00) Coronavirus SARS-CoV2 Rapid: Not Detected (01/20/25 08:29:00) Micro - Last 7 days Rapid Influenza Method: PCR - Liat (01/20/25 08:29:00) Rapid Influenza A PCR: Not Detected (01/20/25 08:29:00) Rapid Influenza B PCR: Not Detected (01/20/25 08:29:00) Diagnostics Radiology Results - Last 24 hours Across Visits 01/20/2025 09:17 - CT Abd/Pelvis W/O IV Contrast IMPRESSION: 1. Status post cholecystectomy and hysterectomy and probablyprevious hiatal hernia repair.2. Mild ascites.3. Bilateral nonobstructing nephrolithiasis.4. Diffuse wall thickening of the colon and rectum consistent withcolitis. Signature Line Electronically Signed on 01/20/25 13:46 ________________________________________________________ MD

Itchy Rash on back, chest & abdomen consistent with pityriasis rosea (Herald lesion on (R) shoulder blade)

Within 24 hours: decreased feeding, within 48 hours, cough/congestion, within 72 hours, peripheral cyanosis of bilateral lower extremities and injection site swelling/redness.

A pregnant woman on her 3rd trimester received a dose of Arexvy.; A pregnant woman on her 3rd trimester received a dose of Arexvy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a adult female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: A pregnant woman on her 3rd trimester received a dose of Arexvy.) and drug use in unapproved population (Verbatim: A pregnant woman on her 3rd trimester received a dose of Arexvy). The outcome of the vaccine exposure during pregnancy and drug use in unapproved population were unknown. Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 10-JAN-2025 The pharmacist reported that they administered a dose of Arexvy to a pregnant woman which led to drug use in unapproved population. The patient was on her 3rd trimester of pregnancy and she was in her mid 30’s of age. The pharmacist asked safety information about this.

The Kinrix was the 2nd in the series; Kinrix was administered to a 5 month old; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis. Concomitant products included Pediarix. On 15-NOV-2024, the patient received the 2nd dose of Kinrix. On 15-NOV-2024, an unknown time after receiving Kinrix and an unknown time after receiving Pediarix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: The Kinrix was the 2nd in the series) and inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a 5 month old). The outcome of the inappropriate schedule of vaccine administered and inappropriate age at vaccine administration were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 26-DEC-2024 Nurse reported that Kinrix was administered to a 5 month old on November 15, 2024. Patient has had no issues. 1st dose of Pediarix on August 23, 2024. The Kinrix was the 2nd in the series which led to Inappropriate schedule of vaccine administered and Inappropriate age at vaccine administration.

Swollen lymph nodes; This non-serious case was reported by a consumer via patient support programs and described the occurrence of swollen lymph nodes in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 19-DEC-2024, the patient received Shingrix. On 20-DEC-2024, 1 days after receiving Shingrix, the patient experienced swollen lymph nodes (Verbatim: Swollen lymph nodes). The outcome of the swollen lymph nodes was not resolved. It was unknown if the reporter considered the swollen lymph nodes to be related to Shingrix. It was unknown if the company considered the swollen lymph nodes to be related to Shingrix. Additional Information: GSK Receipt Date: 23-DEC-2024 The patient self-reported this case for himself. The patient experienced swollen lymph nodes which was ongoing. The patient did not receive other products. No symptoms were treated.

Single Seizure Unspecified Type; This 21-month-old male subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular, right thigh) on 16-OCT-2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 26-APR-2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 26-APR-2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 04-FEB-2019, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous, right arm) on 16-OCT-2019, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous, left arm) on 16-OCT-2019, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. On 05-JUL-2020, 263 days after receiving Bexsero vs Placebo, M-M-R II and Varivax, 436 days after receiving DTPa-HBV-IPV and Hiberix and 517 days after receiving Rotarix lyophilized formulation, the subject developed mild – grade 1 seizure (Verbatim: Single Seizure Unspecified Type). Serious criteria included clinically significant/intervention required. The outcome of seizure was resolved on 05-JUL-2020. Diagnostic results (reference ranges are provided in parenthesis if available): Blood magnesium- 05-JUL-2020 2.4 mg/dL, (1.70-2.30). Body temperature- 05-JUL-2020 98.3 (taken orally). Lymphocyte count- 05-JUL-2020 78.0 percent, (20.00-70.00). The investigator considered that there was no reasonable possibility that the seizure may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix, Rotarix lyophilized formulation, M-M-R II and Varivax. Other possible cause(s) of the seizure included DTPa-HBV-IPV vaccine PRE-FILLED SYRINGE DEVICE and Rotavirus vaccine ORAL APPLICATOR DEVICE. The company considered that there was no reasonable possibility that the seizure may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix, Rotarix lyophilized formulation, M-M-R II and Varivax. 05JUL2020 mother was trying to put subject down to nap, he was crawling to the edge of their bed, but did not fall, and then suddenly went limb. Mom flipped him over, eyes were fluttering, body was limp, lasted about 3 minutes. Did not stop breathing, did not turn blue, did not wet himself. Mom called EMS. The subject regained his strength and Baseline status. He has been doing well recently with no recent illness. No head trauma recently. No family history of epilepsy. Subject was discharged home in stable condition after being observed in Emergency Department for 3 hours. No medications were given. The only procedure done was lab draw for complete blood count (CBC) and Electrolytes. Labs were normal except for Magnesium 2.4 mg/dL (normal range 1.7-2.3 mg/dL) and lymphocytosis ith lymphocytes at 78 percent (normal range 20-70 percent). No other treatments were done. No family history of epilepsy. No previous history of seizures documented in medical record. Loss of consciousness reported. Event occurred more than 48hrs after last vaccination (15NOV2019), so hypotonic hyporesponsive episode excluded. No birth complications reported. No fever. The seizure was witnessed by study parents or relatives. The date of first seizure was 5/Jul/2020 and time of first seizure was unknown. No fever at the time or immediately before generalized convulsive seizure. Duration of seizure in minutes (approximately): 3 minutes. Number of generalized convulsive seizures: 1. No past history of similar events. Familial history of similar events. Type of Seizure: Single Seizure, unspecified type. Diagnostic certainty level: Level 1; Witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations. No Familial history of similar events. Investigator reported SAE term as Single Seizure Unspecified Type. On 28May2021, the SAE Single Seizure Unspecified Type was marked as Other AESI by the Investigator. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Follow up information received on 14-Jan-2025. Summary of changes: General narrative updated. Upon internal review the case was updated on 20-Jan-2025. Route of administration was corrected for Rotarix lyophilized formulation, M-M-R II and Varivax. Anatomical location added for Bexsero vs Placebo, Prevnar 13, Hiberix, M-M-R II, Varivax, device causality updated as unknown.; Sender’s Comments: A case of Seizure, 263 days after receiving the 4th dose of Bexsero vs Placebo and Prevnar 13, 1 st dose of M-M-R II and Varivax, 436 days after receiving 3rd dose of DTPa-HBV-IPV vaccine pre-filled syringe device injection syringe, and Hiberix, 517 days after receiving 2nd dose of Rotarix vaccine oral applicator device, co-administered with PCV and routine vaccines, in a 21-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset.

Complex Febrile Convulsions; Influenza A; This 15-month-old female subject was enrolled in a study The subject received the 4th dose of Bexsero vs Placebo (intramuscular, right thigh) on 18-OCT-2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 26-APR-2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 15-FEB-2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 26-APR-2019, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous, right arm) on 18-OCT-2019, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous, left arm) on 18-OCT-2019, for prophylaxis. The subject received the 4th dose of Prevnar 13 (intramuscular, left thigh) on 18-OCT-2019, for prophylaxis. Concurrent medical conditions included reactive airways disease. On 08-JAN-2020, 82 days after receiving Bexsero vs Placebo, M-M-R II, Varivax and Prevnar 13, 257 days after receiving DTPa-HBV-IPV and Hiberix and 327 days after receiving Rotarix lyophilized formulation, the subject developed moderate – grade 2 influenza a virus infection (Verbatim: Influenza A). Serious criteria included hospitalization. Additional event(s) included severe – grade 3 complex febrile convulsion (Verbatim: Complex Febrile Convulsions) on 13-JAN-2020 with serious criteria of hospitalization. The subject was treated with oxygen, budesonide, salbutamol (Albuterol), sodium chloride, paracetamol (Tylenol), oseltamivir phosphate (Tamiflu) and lorazepam (Ativan). The outcome of influenza a virus infection was resolved on 18-JAN-2020. The outcome(s) of the additional event(s) included complex febrile convulsion (resolved on 13-JAN-2020). Relevant Tests: On 13-JAN-2020 Chest X-Ray No acute cardiopulmonary findings On 14-JAN-2020 CT (Computerised tomogram) Head; No acute pathology seen on the brain On 14-JAN-2020 Influneza Virus A RNA; Positive.. The investigator considered that there was no reasonable possibility that the influenza a virus infection and complex febrile convulsion may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix, M-M-R II, Varivax and Prevnar 13. The company considered that there was no reasonable possibility that the influenza a virus infection and complex febrile convulsion may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix, M-M-R II, Varivax and Prevnar 13. Linked case(s) involving the same subject: US2020029362 GSK Receipt Date: 18-FEB-2020 15 Month girl with history of Reactive Airway Disease and family history of febrile seizures, transferred from ED (emergency department) for 2 complex seizures in 24hrs, found to be influenza A positive. Prior to seizure, subject had cough, congestion and fevers. First seizure occurred 13JAN2020 at daycare, she became unresponsive and had jerking arm movements, followed by emesis and groggy post ictal period with full return to baseline. In the ED (emergency department) had a second seizure approximately 8 minutes in duration requiring Ativan with R arm shaking and unresponsiveness. Febrile to 102.5, labs and head CT normal. Transferred to hospital for further management. During her admission she had no further seizure activity. Neurological exams improved throughout the day on 14JAN2020, early in the day she was drowsy and ataxic, likely due to Ativan administration. No signs of encephalopathy. No further fevers. Further imaging and lumbar puncture deferred secondary to reassuring improvement of neurologic exam and return to baseline per parents. On the day of discharge she developed mild wheezing and intermittent subcostal retractions consistent with her known reactive airway disease symptoms. Exam improved significantly after normal albuterol dose. Subject started on Tamiflu, would continue 5 day course BID. On day of discharge, bilateral tympanic membranes were mild erythematous and had copious earwax, but no bulging, purulent or serous fluid behind tympanic membrane was visualized. Subject admitted to hospital on 13JAN2020 and discharged on 15JAN2020. This child did not experience any infections, trauma or complications at birth. The child’s APGARS were 9 at 1 minute after and 9 at 5 minutes after birth. No seizures were experienced by this child prior to occurrence. Follow-up information received on 12th May 2022 this follow-up was consider as non-significant. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). The seizure was witnessed by study personnel or other health care professional. The date of first seizure was 13/Jan/2020 and time of first seizure was 17:30. Fever at the time or immediately before generalized convulsive seizure: 102.5 degrees Fahrenheit. Duration of seizure in minutes (approximately): 6 minutes. Number of generalized convulsive seizures: 2. No past history of similar events. Familial history of similar events: Yes, but the event was not already reported. Type of Seizure: Febrile seizure. Diagnostic certainty level: Level 1; Witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations. Summary of changes: No new information updated. Follow up information was received on 08-AUG-2024 The subject was received D5 Nacl 0.9% as treatment dose 40 ml/hr, CO via Intravenous on 14-JAN-2020 for complex febrile convulsions The subject was received D5-Nacl 0.9% with KCL as treatment dose 40 ml/hr, CO via Intravenous from 14-JAN-2020 to 15-JAN-2020 for complex febrile convulsions. Summary of changes: Event complex Febrile Convulsions seriousness criteria GSK Medically Significant removed, treatment medication Ativan unit updated from mg to ml, Tylenol frequency updated from Once only to Once daily and narrative updated. Follow up information was received on 14-JAN-2025 Summary of changes: General narrative comments and unit update for oxygen.; Sender’s Comments: A case of Influenza and Febrile convulsion 82 days after receiving 4th doses of Bexsero vs Placebo and Prevnar 13, 1st doses of M-M-R II and Varivax, 257 days after receiving 3rd doses of DTPa-HBV-IPV and Hiberix, and 327 days after receiving 2nd dose of Rotarix lyophilized formulation, in a 15-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausability (for Bexsero vs Placebo, Rotarix lyophilized formulation, M-M-R II, Varivax and Prevnar 13) and alternative etiology (Influenza A positive) and alternative risk factors (h/o Reactive Airway Disease, family history of febrile seizures and fever contributed by underlying infection). US-GLAXOSMITHKLINE-US2020029362:

Febrile Seizure; This 13-month-old male subject was enrolled in a study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular, right thigh) on 12-SEP-2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 08-MAR-2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 08-MAR-2019, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous, right arm) on 12-SEP-2019, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous, left arm) on 12-SEP-2019, for prophylaxis. Co-suspect products included Rota (Rotarix liquid formulation) for prophylaxis and Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. On 01-NOV-2019, 50 days after receiving Bexsero vs Placebo, M-M-R II and Varivax and 238 days after receiving DTPa-HBV-IPV and Hiberix, the subject developed severe – grade 3 febrile seizure (Verbatim: Febrile Seizure). Serious criteria included clinically significant/intervention required. The subject was treated with ibuprofen (Children’S Ibuprofen) and paracetamol (Tylenol Infant). The outcome of febrile seizure was resolved on 01-NOV-2019. Relevant Tests: On 02Nov2019, Urine culture was performed. Findings showed “mixed organisms are present indicating probable contamination or colonization not related to infection”. On 02Nov2019, Urinalysis was performed. Results showed “cloudy” appearance-normal would be “clear”. All other tests were within normal units for the urinalysis.. Diagnostic results (reference ranges are provided in parenthesis if available): Body temperature- 01-NOV-2019 102.2 degree F and in NOV-2019 38.8 degree C. The investigator considered that there was no reasonable possibility that the febrile seizure may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix, M-M-R II and Varivax. The company considered that there was no reasonable possibility that the febrile seizure may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix, M-M-R II and Varivax. GSK Receipt Date: 05-NOV-2019 Thirteen month old who was brought to the Emergency Department for an episode of altered mental status. The child was noted to be playful and active in the morning of 01Nov2019 by his grandmother. He was picked up by Mom after her work and Mom noted that the child “went limp”, staring off into space with eyes open, head flopped back and extremities went limp”. Mom noted “no eye movements or convulsions of extremities. No urinary incontinence. No apnea or cyanosis. He was limp for about two minutes then was very sleepy/hard to engage or arouse for some forty to sixty minutes”. Parents noted later the child shivering and having intermittent chills. In the Emergency Department the child had a temperature of 38.8 degree C and pulse of 185. A urine analysis and urine culture were ordered, and obtained the following day on 02Nov2019. The child was given PO Motrin in the Emergency Department on 01Nov2019. The child was discharged on 01Nov2019 to home with a diagnosis of Febrile Seizure. Before discharge he was afebrile, adequately hydrating. The tachycardia was likely related to his fevers. Teaching was discussed regarding antifebrile medications as well as aggressive oral rehydration. The child was discharged in good condition on 01Nov2019. The child continued on around the clock Motrin and Tylenol alternating each medication until 03Nov2019. He was seen for follow-up on 02Nov2019. And was noted that the fever was “likely viral source”. The child had no symptoms of pneumonia, or evidence of urinary tract infection. Spoke to Mom on 04Nov2019, per Mom “He’s back to normal, no fevers, doing well”. Addendum: Mom reported the duration of the seizure to be approximately 2 minutes (17:30). she also reported that the child’s uncle had one febrile seizure when he was a boy. This child was born full term, had a normal delivery with no infections, trauma or complications. Hi APGARS were 8 at 1 minute after birth and 9 at 5 minutes after birth. He was diagnosed with a “Simple febrile seizure”. He had no post history of hypotonic, hyporesponsive episodes or absence seizures. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). The Seizure was Witnessed by parents or relatives. Date of first Seizure was 1/Nov/2019 and Time of first Seizure was 17:30. Body temperature (fever) at the time of generalized convulsive seizure was 102.2 degrees Fahrenheit. Duration of seizure in minutes (approximately) was 2 minutes. Number of generalized convulsive seizures was 1. There was no past history of similar events. There was familial history of similar events but the event was not already reported. Type of Seizure was Febrile Seizure with fever, Subject’s mom reported her brother had one febrile seizure. Diagnostic certainty level was Level 1; Witnessed sudden loss of consciousness and generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Follow up information received on 15-JAN-2025 Summary of changes: General narrative comments updated. The start date and time of event febrile seizure was 1-NOV-2019 17:30 Upon internal review case was updated on 21-JAN-2025 Co-suspect vaccines DTPa-HBV-IPV, Hiberix,,MMR II, Varivax start date updated.; Sender’s Comments: A case of Febrile convulsion, 50 days after receiving 4th dose of Bexsero vs Placebo, 1st dose of M-M-R II and Varivax and Prevnar 13, 238 days after receiving 3rd dose of DTPa-HBV-IPV vaccine and Hiberix and 298 days after Rotarix liquid formulation, in a 13-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative risk factor (family h/o febrile seizure and multiple concomitant vaccines).